Chapitre 1. European Survey on Ethical and Legal Framework of Clinical Trials in Paediatrics: Results and Perspectives

Off-label antibiotic use in children in three European countries

“…Furthermore, the limited pediatric drug research that is carried out is often based on small-scale studies that lack the statistical power necessary to draw any firm conclusions concerning the real efficacy of the drugs or their long-term toxic effects [14]. Ethical conflicts are heightened where the toxicity of medicines may be different in children and adults, compounded by issues around informed consent and assent [15].…”

Changes in Research and Development of Medicinal Products since the Paediatric Regulation

“…In fact, on the basis of the assumptions that the paediatric population has the right to use medicines that have been appropriately evaluated and tested, and that it represents a vulnerable subgroup, the guideline introduces special measures to protect the rights of paediatric study participants and to shield them from undue risk. , 2006a, 2006b), that is expected to increase the number of clinical trials carried out in the paediatric population, has highlighted the limits of the existing clinical trials legislation in particular with reference to children data protection, direct involvement into the 'consensus process' and respect of the children will during the entire clinical research (Altavilla et al, 2008). In February 2008, the European Commission released updated recommendations on ethical aspects of clinical trials involving children (European Commission's Directorate-General for Health and Consumers, 2008) to tackle the weakness of the existing rules.…”

“…All of the above mentioned 'set of rules' valuable for protecting children during trials have represented a real advancement to assure a superior ethical context for children involved in a clinical trials. Nevertheless, some important surveys and enquires (Altavilla et al, 2008(Altavilla et al, , 2011 ), suffered the lack of binding rules and EU guided coordination activities that led to great differences in children protection levels in different Member States. Such disparities are particularly relevant when related to consent/assent procedures, to the respect of the children's will, and to other fundamental rights (e.g., confidentiality and information).…”

Ethical key issues and fundamental rights in paediatric research

“…and national regulations [31]. Many differences exist in Europe related to the guarantees of children rights, to the protection of minors involved in clinical trials across Europe as well as to the ethical reviewing of paediatric protocols [32,33].…”

“…Some countries go beyond the requirements of the Directive: for instance they assure more importance to the will of the minors (Spain) or consider their will necessary to involve them in clinical trials (Denmark, Estonia and the Netherlands). The expression of will is accepted at different age limits (12 years in Spain, 15-17 years in Denmark, 7-17 years in Estonia, 12 years in The Netherlands) [31,32]. With reference to acceptable risk and burden for children involved in clinical research, Greece, Ireland, Italy, and Belgium would seem to follow the more liberal Directive (requiring "minimising" risk and burden, also if there is only group benefit).…”